Drug Safety Specialist I
455 Mission Bay Blvd. (South) San Francisco, CA 94158 | Contract
Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize technology platforms, which are designed to improve the benefits of drugs for patients.
- Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies.
- Develops guidelines and insures the uniform and timely processing of adverse event reports.
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
- Develops and prepares reports for company management as well as external regulatory agencies.
- Assists in the preparation of safety updates for investigational new drug and new drug applications, investigator communications, product labeling/package inserts and other reports as necessary.
- May work with data management in the ongoing development of case report forms for clinical trials and maintenance of databases.
- Performing complete data entry of serious adverse events received from clinical trials, according to the Company workflow processes and standard operating procedures.
- Generate initial case narratives based on information received as part of source documents including but not limited to, case report forms, hospital admission notes, history and physical (H&P) consult notes, progress notes, lab results, results of diagnostic, radiological and other tests, discharge summaries, death certificate and autopsy results provided by the study sites.
- Draft appropriate initial queries for outstanding information or incomplete data and communicate the queries to study site personnel following review and approval of the queries by a senior Company Drug Safety person.
- Communicate or notify the Company drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines.
- Maintain and track all serious adverse events reported from the Company sponsored clinical trials for case processing relative to their priorities and submission deadlines.
- Support Drug Safety Department initiatives on ad hoc (as needed) basis.
- Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events.
- Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally.
- Ensure compliance with the Company' s SOPs.
- Experience in oncology therapeutic area is preferred but not mandatory.
- Familiarity with Medical terminology required.
- Ability to process data entry accurately.
- Ability to code and map data accurately.
- Concise case narrative (medical) writing experience preferred.
- Ability to prioritize work without much support.
- Clear effective written and verbal communication skills are essential for effective communication with study sites.
- Focused and detail oriented.
- Work effectively as a team member, promote collaboration.
- Self starter and self accountability.
- Relevant industry experience is highly preferred.
- High level of work conduct.
- A Bachelors degree in a scientific discipline is required.
- RN or BSN degree is highly desired.
- Equivalent experience may be accepted.
- A minimum of two years experience in Drug safety or Pharmacovigilance, with at least one year’s hands-on experience in serious adverse event management in clinical trials evaluating investigational products is required.